The purpose of this study is to evaluate the efficacy of ST266 ophthalmic drops compared to placebo for the treatment of the signs and symptoms of allergic conjunctivitis.
The study is a multi-center, double-masked, randomized, placebo-controlled, modified conjunctival allergen challenge (CAC) model. The primary endpoints of ocular itching and conjunctival redness will be evaluated at the subject's final visit. Subjects who meet inclusion criteria will be randomized to one of two treatment groups (1:1). Randomization will be stratified by average post-CAC itching scores at baseline. Subjects will be evaluated at baseline and on Days 6, 7 and 8.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
70
One (1) drop of 1X ST266 ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
One (1) drop of saline ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
Unnamed facility
Andover, Massachusetts, United States
Unnamed facility
Memphis, Tennessee, United States
Ocular Itching
Ocular itching evaluated by the subject. Ocular itching was evaluated on a 0-4 scale (with half unit increments allowed). Lower scores indicated less itching.
Time frame: Day 7 and 8
Conjunctival Redness
Conjunctival redness evaluated by the investigator. Conjunctival redness was evaluated on a 0-4 scale (with half unit increments allowed). Lower scores indicated less redness.
Time frame: Day 7 and 8
Ciliary Redness
Ciliary redness evaluated by the investigator. Ciliary redness was evaluated on a 0-4 scale (with half unit increments allowed). A lower score was indicative of less redness.
Time frame: Day 7 and 8
Episcleral Redness
Episcleral redness evaluated by the investigator. Episcleral redness was evaluated on a 0-4 scale (with half unit increments allowed). A lower score was indicative of less redness.
Time frame: Day 7 and 8
Chemosis
Chemosis evaluated by the investigator. Chemosis was evaluated on a 0-4 scale (with half unit increments allowed). A lower score was indicative of less chemosis.
Time frame: Day 7 and 8
Eyelid Swelling
Eyelid swelling evaluated by the subject. Eyelid swelling was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less swelling.
Time frame: Day 7 and 8
Tearing/Watery Eyes
Tearing evaluated by the subject. Tearing was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less tearing.
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Time frame: Day 7 and 8
Rhinorrhea
Rhinorrhea evaluated by the subject. Rhinorrhea was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less severity.
Time frame: Day 7 and 8
Nasal Pruritus
Nasal Pruritus evaluated by the subject. Nasal pruritus was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less severity.
Time frame: Day 7 and 8
Ear or Palate Pruritus
Ear or palate pruritus evaluated by the subject. Ear or palate pruritus was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less severity.
Time frame: Day 7 and 8
Nasal Congestion
Nasal congestion evaluated by the subject. Nasal congestion was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less severity.
Time frame: Day 7 and 8
Nasal Composite Score
A composite score of presence or absence of at least one nasal symptom evaluated by the subject
Time frame: Day 7 and 8